www.fdanews.com/articles/103735-migenix-amends-protocol-in-hepatitis-c-study
Migenix Amends Protocol in Hepatitis C Study
February 5, 2008
Migenix will add a 600-mg celgosivir combination therapy arm to its Phase II study in treatment-naive hepatitis C patients.
The 12-week, randomized, active-controlled study initially enrolled 20 patients in two treatment arms: peginterferon alfa-2b plus ribavirin and the combination plus 400-mg celgosivir.
The approved protocol amendment allows for the addition of the 600-mg arm and the flexibility to increase the number of patients in the study to a maximum of 50, Migenix said.